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Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of Maryland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ting Bao, University of Maryland
ClinicalTrials.gov Identifier:
NCT01541644
First received: February 20, 2012
Last updated: December 10, 2013
Last verified: November 2012
  Purpose

Patients are asked to be in this study if they have multiple myeloma and are having tingling, numbness and pain from taking bortezomib (velcade®). Patients who have been diagnosed with multiple myeloma often take bortezomib (velcade®).

This research is being done to find out if acupuncture can reduce the nerve pain, tingling, and/or numbness patients experience due to bortezomib (velcade®).

Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and nerve pain. In this study we will see if acupuncture can be used to ease nerve pain and tingling, numbness that is caused by bortezomib.


Condition Intervention
Peripheral Neuropathies
Multiple Myeloma
Device: Acupuncture

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • To determine the response rate, effectiveness and safety of acupuncture in alleviating neuropathic symptoms when treating patients with moderate to severe Bortezomib-induced Peripheral Neuropathy (BIPN). [ Time Frame: Week 10 ] [ Designated as safety issue: Yes ]

    Response is defined as the average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks as compared to baseline. Effect is defined as as the average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline.

    Safety will be assessed by recording side effects from acupuncture treatment.



Secondary Outcome Measures:
  • To assess if acupuncture treatment is associated with reduced oral analgesic use in patients with BIPN. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • To assess if acupuncture treatment is associated with changes in neurologic examination and nerve conduction studies. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • To explore the mechanisms of acupuncture in treating BIPN by studying the changes in proinflammatory cytokines and beta endorphins. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • To determine if the study's acupuncture schedule is feasible in treating multiple myeloma patients with BIPN. [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.


Estimated Enrollment: 25
Study Start Date: May 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
All participants will receive acupuncture treatments over a total of 10 weeks.
Device: Acupuncture
Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

Detailed Description:

Information gained from this clinical trial will provide insight into the efficacy and mechanism of acupuncture in reducing Bortezomib-induced Peripheral Neuropathy (BIPN) in multiple myeloma patients. It will examine the effect of acupuncture on serum proinflammatory cytokine and β-endorphin levels to further understand the mechanism of acupuncture on a molecular level. This study is the first clinical trial studying the effect of acupuncture on treating BIPN. It is also the first study to explore the mechanism of acupuncture through frequent small amount of blood draws at six time points to detect changes in proinflammatory cytokines and β-endorphins. It has the potential to identify a minimal risk non-pharmacological intervention to alleviate BIPN symptoms, and to significantly improve our understanding of the mechanism of acupuncture.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma.
  • Greater than or equal to grade 2 BIPN as defined by the National Cancer Institute - -Common Toxicity Criteria (NCI-CTC) 4.0.
  • BIPN symptoms persist after bortezomib has been discontinued.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
  • Men and women who are ≥ 18 years old
  • The patient is aware of the nature of his or her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria:

  • Prior acupuncture within the past month.
  • Life expectancy is < 3 months.
  • Plan to go on experimental drug for multiple myeloma that is known to cause peripheral neuropathy in the next 14 weeks.
  • Concomitant treatment with chemotherapy, unless approval is given by the Principal Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541644

Locations
United States, Maryland
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Ting Bao, MD, DABMA University of Maryland Marlene & Stewart Greenebaum Cancer Center
  More Information

No publications provided

Responsible Party: Ting Bao, Assistant Profressor, University of Maryland
ClinicalTrials.gov Identifier: NCT01541644     History of Changes
Other Study ID Numbers: HP-00047788, GCC 1068
Study First Received: February 20, 2012
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Acupuncture Therapy
bortezomib-induced peripheral neuropathy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Peripheral Nervous System Diseases
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Neuromuscular Diseases
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014